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Unit 4: GLP, GCP and GMP - Practice Quiz

BTY196 — Biosafety And Bioethics 60 Questions
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1 What does the abbreviation GLP stand for?

Good Laboratory Practices (GLP) and its application Easy
A. Good Laboratory Practices
B. Guided Laboratory Procedures
C. General Laboratory Protocols
D. Global Laboratory Practices

2 What does the abbreviation GMP stand for?

Good manufacturing practices (GMP) Easy
A. Global Manufacturing Policy
B. Good Manufacturing Practices
C. General Manufacturing Protocols
D. Guided Material Processing

3 What does the abbreviation GCP stand for?

Good clinical practices (GCP) Easy
A. Global Clinical Policy
B. Good Clinical Practices
C. General Clinical Protocols
D. Guided Clinical Procedures

4 What does the abbreviation SOP stand for?

Standard operating procedure (SOP): Introduction, preparation, validation and revision Easy
A. Systematic Operating Plan
B. Structured Operating Practice
C. Standard Operating Procedure
D. Standard Operational Protocol

5 GLP regulations were first introduced by which country's regulatory agency?

Introduction: History, definition, Principles Easy
A. Germany (BfArM)
B. United States (FDA)
C. Japan (PMDA)
D. United Kingdom (MHRA)

6 GLP is primarily concerned with which type of studies?

Good Laboratory Practices (GLP) and its application Easy
A. Marketing surveys
B. Clinical trials on patients
C. Non-clinical safety studies
D. Financial audits

7 The FDA stands for which of the following?

GLP and FDA Easy
A. Federal Drug Agency
B. Food and Drug Administration
C. Federal Drug Association
D. Food Distribution Authority

8 GCP is applied specifically to studies involving which subjects?

Good clinical practices (GCP) Easy
A. Chemical compounds
B. Laboratory animals
C. Human subjects
D. Manufacturing equipment

9 The main goal of GMP is to ensure that products are:

Good manufacturing practices (GMP) Easy
A. Produced in the largest quantity
B. Sold at the lowest price
C. Consistently produced to quality standards
D. Advertised effectively

10 In GLP, the unit responsible for monitoring that studies comply with GLP principles is the:

GLP: training, resources, rules, characterization, documentation, quality assurance Easy
A. Quality Assurance Unit (QAU)
B. Finance Committee
C. Human Resources Unit
D. Marketing Department

11 Under GLP, personnel performing studies must have appropriate:

GLP: training, resources, rules, characterization, documentation, quality assurance Easy
A. Marketing skills
B. Training and qualifications
C. Sales targets
D. Legal degrees

12 GLP principles were largely harmonized internationally by which organization?

Introduction: History, definition, Principles Easy
A. UNESCO
B. OECD
C. WTO
D. WHO

13 The person with overall responsibility for the conduct of a GLP study is the:

GLP: training, resources, rules, characterization, documentation, quality assurance Easy
A. Study Director
B. Auditor
C. Sponsor
D. Technician

14 The main purpose of an SOP is to ensure that tasks are performed:

Standard operating procedure (SOP): Introduction, preparation, validation and revision Easy
A. Faster without records
B. Without documentation
C. Only by senior staff
D. Consistently and uniformly

15 When an SOP becomes outdated, it should be:

Standard operating procedure (SOP): Introduction, preparation, validation and revision Easy
A. Revised and re-approved
B. Ignored during work
C. Used as it is
D. Deleted without record

16 Under GLP, laboratory equipment used for generating data must be regularly:

Facilities: building and equipment Easy
A. Calibrated and maintained
B. Replaced weekly
C. Shared without records
D. Left uncleaned

17 In GLP, the term 'characterization' most closely refers to identifying the properties of the:

GLP: training, resources, rules, characterization, documentation, quality assurance Easy
A. Test and reference items
B. Building layout
C. Company logo
D. Staff uniforms

18 Compliance monitoring in GLP is typically carried out through:

Stepwise implementation of GLP and compliance monitoring Easy
A. Sales reviews
B. Inspections and audits
C. Advertising campaigns
D. Random guessing

19 A key GLP requirement for facilities is having adequate space to:

Facilities: building and equipment Easy
A. Store personal belongings
B. Host social events
C. Prevent contamination and mix-ups
D. Display advertisements

20 In GLP, complete and accurate records of a study are important mainly because they ensure data are:

GLP: training, resources, rules, characterization, documentation, quality assurance Easy
A. Kept secret from auditors
B. Optional to maintain
C. Discarded quickly
D. Traceable and reconstructable

21 The formal development of GLP regulations was largely triggered in the 1970s by which event?

Introduction: History, definition, Principles Medium
A. Detection of fraudulent and poor-quality data from toxicology testing laboratories
B. The launch of the Human Genome Project
C. Discovery of PCR technology
D. Introduction of recombinant DNA guidelines

22 A laboratory conducting non-clinical safety studies on a new pesticide must follow GLP primarily to ensure:

Good Laboratory Practices (GLP) and its application Medium
A. Faster commercial production
B. Lower cost of raw materials
C. The quality, integrity, and reliability of the study data
D. Marketing approval without any inspection

23 Under GLP, if a technician's signature appears on a study record, the facility must be able to demonstrate that the technician:

GLP: training, resources, rules, characterization, documentation, quality assurance Medium
A. Is a member of the quality assurance unit
B. Has documented training and qualification for that task
C. Was hired within the last year
D. Has a postgraduate degree

24 In GLP, the Quality Assurance Unit (QAU) must remain:

GLP: training, resources, rules, characterization, documentation, quality assurance Medium
A. Part of the marketing department
B. Independent from the personnel conducting the study
C. Responsible for writing the study protocol
D. Under the direct control of the study director

25 The term "characterization" in GLP refers primarily to:

GLP: training, resources, rules, characterization, documentation, quality assurance Medium
A. Labeling equipment with serial numbers
B. Classifying the laboratory building type
C. Describing the personality traits of the study director
D. Determining the identity, strength, purity, and stability of the test item

26 A raw data entry in a GLP study is found to contain an error. According to GLP documentation rules, the correct action is to:

GLP: training, resources, rules, characterization, documentation, quality assurance Medium
A. Discard the page and start a fresh record
B. Erase the entry and write the correct value
C. Use correction fluid to cover it and rewrite
D. Cross out with a single line, add the correct value, date, and initial it

27 Why does GLP require separate areas for test system handling and test item storage within a facility?

Facilities: building and equipment Medium
A. To prevent cross-contamination and mix-ups
B. To increase the number of employees needed
C. To reduce electricity consumption
D. To speed up product shipment

28 A balance used in a GLP study must be regularly calibrated. The main GLP purpose of calibration records is to:

Facilities: building and equipment Medium
A. Prove the balance is expensive
B. Demonstrate that measurements are accurate and traceable
C. Reduce the cost of equipment purchase
D. Show how many people use the balance

29 Under FDA GLP regulations (21 CFR Part 58), the individual with overall responsibility for the technical conduct of a study and interpretation of results is the:

GLP and FDA Medium
A. Study director
B. Sponsor's marketing head
C. Facility maintenance officer
D. Quality assurance auditor

30 If an FDA inspection reveals major GLP non-compliance in a submitted study, the most likely consequence is that:

GLP and FDA Medium
A. The data may be rejected and the study repeated
B. The FDA automatically approves the product faster
C. The study director is promoted
D. The laboratory receives a research grant

31 When implementing GLP in a new laboratory, which step logically comes first?

Stepwise implementation of GLP and compliance monitoring Medium
A. Conducting the final study report
B. Marketing the finished product
C. Management commitment and appointing responsible personnel
D. Submitting data to regulators

32 Compliance monitoring in GLP is typically carried out through:

Stepwise implementation of GLP and compliance monitoring Medium
A. Periodic inspections and audits by the QAU and regulatory authorities
B. Annual staff parties
C. Reducing the number of SOPs each year
D. Random advertisements of the facility

33 A pharmaceutical company finds two batches of a tablet differ significantly in dissolution rate. GMP would address this mainly through:

Good manufacturing practices (GMP) Medium
A. Ensuring process control and validation to achieve batch-to-batch consistency
B. Reducing quality control testing
C. Increasing the marketing budget
D.
E. Ignoring the difference if both pass visual inspection

34 The "C" in cGMP (as used by regulatory agencies) stands for:

Good manufacturing practices (GMP) Medium
A. Cheap
B. Clinical
C. Current
D. Certified

35 Which activity is a core GMP concern rather than a GLP concern?

Good manufacturing practices (GMP) Medium
A. Interpreting animal study safety data
B. Designing a research protocol for a pilot study
C. Non-clinical toxicity testing of a new molecule
D. Ensuring quality control during routine drug production

36 A cornerstone ethical requirement of GCP before enrolling a participant in a clinical trial is:

Good clinical practices (GCP) Medium
A. Guaranteeing the drug will work
B. Obtaining voluntary informed consent
C. Publishing the trial results first
D. Payment of a registration fee by the participant

37 In GCP, the body responsible for reviewing and approving a clinical trial protocol to protect participant rights is the:

Good clinical practices (GCP) Medium
A. Marketing authorization board
B. Institutional Review Board / Ethics Committee
C. Purchase department
D. Manufacturing quality unit

38 GCP applies primarily to which of the following activities?

Good clinical practices (GCP) Medium
A. Animal-only toxicology studies
B. Bulk chemical synthesis in a factory
C. Calibration of laboratory balances
D. Design, conduct, recording, and reporting of trials involving human subjects

39 The main purpose of a Standard Operating Procedure (SOP) in a GLP/GMP setting is to:

Standard operating procedure (SOP): Introduction, preparation, validation and revision Medium
A. Ensure tasks are performed consistently and correctly by everyone
B. Eliminate the need for record keeping
C. Replace the need for trained staff
D. Serve as a marketing document

40 An outdated SOP still contains a superseded method. According to good practice, the revised SOP should:

Standard operating procedure (SOP): Introduction, preparation, validation and revision Medium
A. Remain in use until it physically wears out
B. Simply be edited in pencil by any technician
C. Be deleted without any record of change
D. Be issued with a new version number, dated, and approved, with old copies withdrawn

41 The OECD Principles of GLP were first formally adopted in 1981 following regulatory failures in the 1970s. Which underlying rationale best explains why GLP emerged as a data quality framework rather than a scientific validity framework?

Introduction: History, definition, Principles Hard
A. GLP was introduced to standardize statistical significance thresholds for toxicology studies
B. GLP was designed to guarantee that study conclusions are scientifically correct and reproducible across all laboratories
C. GLP replaced peer review as the primary mechanism for validating experimental design
D. GLP was created to ensure the integrity, traceability, and reconstructability of non-clinical safety data, not to judge the scientific merit of the hypothesis

42 A contract research organization performs an in vitro screening assay to rank drug candidates for a client's internal decision-making, with no intent to submit the data to a regulatory authority. A basic exploratory research study is also being run. Which statement correctly characterizes GLP applicability?

Good Laboratory Practices (GLP) and its application Hard
A. Neither study strictly requires GLP, since GLP applies to non-clinical health and environmental safety studies intended for regulatory submission
B. GLP applies to any study performed within a laboratory regardless of purpose
C. Both studies must be conducted under full GLP because they involve chemicals
D. Only the exploratory research study requires GLP compliance

43 During a GLP audit, the QA unit discovers that a raw data value in a study notebook was corrected using correction fluid, with no signature or date. What is the most defensible corrective action under GLP documentation principles?

GLP: training, resources, rules, characterization, documentation, quality assurance Hard
A. Require the study director to re-run the entire study to eliminate the questioned data
B. Document the deviation, retain the original entry as an audit-recognized error, and reinforce the single-line strike-through, initial, and date rule
C. Discard the entire notebook page and rewrite it from memory to maintain a clean record
D. Accept the correction since the final value is scientifically correct

44 In a GLP study the QA unit reports directly to senior management and is explicitly excluded from involvement in the conduct of the study. What is the primary reason for this structural independence?

GLP: training, resources, rules, characterization, documentation, quality assurance Hard
A. To ensure QA can substitute for the study director when needed
B. To preserve objectivity so QA inspections and audits are free from conflict of interest with those generating the data
C. To allow QA to make scientific decisions about study design
D. To reduce personnel costs by using QA staff for multiple studies

45 Under the FDA's GLP regulations (21 CFR Part 58), the Study Director holds a specific pivotal role. Which responsibility is uniquely and non-delegably the Study Director's under this framework?

GLP and FDA Hard
A. Manufacturing the test article under GMP conditions
B. Approving the facility's master schedule and budget
C. Performing the routine QA inspections of each study phase
D. Serving as the single point of study control and overall responsibility for the technical conduct and final reporting of the study

46 An FDA inspection under 21 CFR Part 58 finds that a study's protocol was amended after study initiation but the amendment was neither dated nor approved by the study director. Which conclusion is most consistent with FDA GLP requirements?

GLP and FDA Hard
A. The QA unit should retroactively approve the amendment to close the finding
B. The study must be immediately terminated and reported as fraud
C. The amendment is valid because protocols can be changed informally during a study
D. The change constitutes a GLP deviation because protocol amendments must be documented, justified, dated, and approved by the study director

47 A GLP toxicology facility houses test-article storage, animal rooms, and necropsy in adjacent areas. An inspector cites the facility for inadequate separation. Which principle most directly underlies this citation?

Facilities: building and equipment Hard
A. Separation is required only to comply with fire safety codes
B. Buildings must maximize floor space efficiency to reduce operating costs
C. All rooms in a GLP facility must be identical in size and layout
D. Facilities must provide adequate degree of separation to prevent cross-contamination and mix-ups that could compromise study integrity

48 A balance used to weigh test article in a GLP study is calibrated annually per SOP, but the calibration record for the current study period is missing though the instrument functions correctly. From a GLP standpoint, what is the core problem?

Facilities: building and equipment Hard
A. The study director may sign a statement that the balance was accurate to close the gap
B. The problem is trivial since the balance works fine
C. Without documented calibration and maintenance records, the accuracy of the data generated cannot be demonstrated, undermining data integrity
D. The balance must be discarded because it is unreliable

49 When implementing GLP in a laboratory transitioning from research to regulatory studies, which sequence reflects the most logical stepwise approach?

Stepwise implementation of GLP and compliance monitoring Hard
A. Purchase all new equipment first, then hire QA staff only after the first inspection
B. Establish management commitment and organization, develop SOPs and facilities, train personnel, then implement QA monitoring before conducting GLP studies
C. Appoint a study director and start data collection, deferring documentation until study completion
D. Begin regulatory studies immediately, then write SOPs and appoint QA as issues arise

50 A national GLP Compliance Monitoring Authority conducts inspections and study audits. What distinguishes a study audit from a routine facility inspection in the OECD compliance monitoring framework?

Stepwise implementation of GLP and compliance monitoring Hard
A. A study audit reviews general facility organization while an inspection reviews a single study's raw data
B. A study audit is performed only by the test facility's own QA, never by the monitoring authority
C. There is no functional difference; the terms are interchangeable
D. A study audit compares raw data and records against the final report for a specific study, while an inspection assesses the facility's overall compliance status

51 A pharmaceutical batch passes all final release specifications, but investigators discover an unrecorded deviation in the mixing step. Under GMP principles, what is the most appropriate action?

Good manufacturing practices (GMP) Hard
A. Retest only the affected step and release if it passes
B. Release the batch immediately because final testing confirms quality
C. Reject or quarantine the batch pending a documented deviation investigation, since GMP quality is built in through the process, not tested in at the end
D. Ignore the deviation because it occurred earlier in the process

52 GMP requires that critical manufacturing processes be validated. Which scenario best illustrates the distinction between process validation and routine in-process control?

Good manufacturing practices (GMP) Hard
A. Validation checks each unit during production; in-process control is done once before launch
B. Validation and in-process control are the same activity performed by different departments
C. Validation is only required after a product has failed several batches
D. Validation provides documented evidence that a process consistently yields product meeting specifications; in-process control monitors defined parameters during each production run

53 In an ICH-GCP trial, a subject signs the informed consent form, but the version signed was superseded by an IRB-approved updated version issued two weeks earlier. What is the most serious GCP implication?

Good clinical practices (GCP) Hard
A. The site should simply backdate the new consent form to match enrollment
B. The consent is a GCP violation because subjects must consent using the current IRB/IEC-approved version, affecting the validity of enrollment and data
C. The subject must be withdrawn and their prior data destroyed
D. No implication, since any signed consent form is acceptable

54 ICH-GCP is built on 13 core principles. Which statement best captures the ethical hierarchy embedded in these principles when a conflict arises?

Good clinical practices (GCP) Hard
A. Investigator convenience determines how conflicts are resolved
B. The rights, safety, and well-being of the trial subjects prevail over the interests of science and society
C. Scientific and societal interests always take precedence over individual subject welfare
D. The sponsor's commercial timeline takes precedence to ensure trial completion

55 A laboratory has an approved SOP but analysts consistently perform an extra rinse step not described in it, arguing it improves results. From an SOP governance standpoint, which response is correct?

Standard operating procedure (SOP): Introduction, preparation, validation and revision Hard
A. Either revise the SOP through the controlled change process to include the step, or stop performing it; work must match the approved SOP
B. Delete the SOP entirely since analysts know the procedure better
C. Allow the deviation but instruct analysts not to document it
D. Analysts may deviate freely as long as results improve

56 An organization maintains SOPs with version control and a periodic review cycle. During review, an SOP is found still accurate and needs no content change. What is the best practice for handling its revision status?

Standard operating procedure (SOP): Introduction, preparation, validation and revision Hard
A. Delete the review requirement since the document is stable
B. Document the review with date and reviewer signature, confirming continued validity without changing the version number
C. Automatically increment the version number to show activity even without changes
D. Withdraw the SOP because unchanged documents are obsolete

57 GLP requires characterization of the test and reference items. For a test article that is a mixture, which characterization requirement is most critical to ensuring study reconstructability?

GLP: training, resources, rules, characterization, documentation, quality assurance Hard
A. Only the color and physical appearance need to be recorded
B. Only the manufacturer's name is required
C. The identity, strength, purity, composition, and stability under storage and test conditions must be documented
D. Characterization is unnecessary for mixtures since they vary naturally

58 A GLP facility maintains training records showing a technician was trained on an SOP dated after the technician had already performed the procedure in a study. What is the fundamental GLP concern?

GLP: training, resources, rules, characterization, documentation, quality assurance Hard
A. Only the trainer, not the technician, needs to be qualified
B. The training date is irrelevant as long as the study passed QA
C. No concern, since the technician eventually became qualified
D. Personnel must be demonstrably trained and qualified before performing GLP tasks, so the data generated by an untrained operator is questionable

59 The FDA GLP regulations require a QAU to maintain a master schedule. Which purpose does the master schedule primarily serve during an FDA inspection?

GLP and FDA Hard
A. It provides an index of all GLP studies by test system, sponsor, and status, enabling inspectors to assess facility workload and select studies for audit
B. It is a marketing document showing the facility's capabilities to sponsors
C. It records only the final approved reports of completed studies
D. It lists employee salaries and shift assignments

60 A single facility conducts a non-clinical toxicology study under GLP, manufactures the drug substance under GMP, and later tests it in humans under GCP. Which statement best distinguishes the primary object of quality protection across these three frameworks?

Introduction: History, definition, Principles Hard
A. GLP protects the integrity of non-clinical safety data, GMP protects the quality and consistency of the manufactured product, and GCP protects the rights and safety of human subjects and clinical data integrity
B. GLP, GMP, and GCP all protect the same object: laboratory equipment
C. All three frameworks primarily protect the manufacturer's commercial interests
D. GMP protects data, GLP protects patients, and GCP protects manufacturing
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